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MDCG Guidance on Ventilators MDCG

MDCG Guidance on Ventilators

The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, focused on the improvement of the medical devices` regulatory framework, published regulatory requirements for ventilators and related accessories. Regulatory Background  ...

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MDCG Guidance on Significant Changes

The Medical Devices Coordination Group (MDCG), an advisory body of the European Commission, issued a guidance document dedicated to the significant changes to medical devices subject to regulation under the Medical Devices Directive 93/42/EEC (MDD) or Active...

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FDA Policy on Diagnostics Testing for COVID-19

The Food and Drug Administration (FDA), the US authority responsible for medical device regulation, issued guidance for clinical laboratories dedicated to Coronavirus Disease-2019 during the public health emergency. The document covers the aspects related to molecular...

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